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The Comeback
Varenicline is back to support your patients to be smoke-free
Prescribing InformationSince June 2021, you and your patients have had no access to varenicline
Varenicline improves smoking abstinence at ~4 weeks, 3 months and 1 year vs combination NRT, high-dose (>22mg) nicotine patches and bupropion3*
In a direct clinical trial comparison with a 24-hour nicotine patch, varenicline had a significantly greater continuous abstinence rate for the last 4 weeks of the treatment period.4†
†12 weeks of varenicline treatment versus 10 weeks of NRT patch.4(as per manufacturer's dosing regimens)
Varenicline has demonstrated efficacy and tolerability across a broad range of smoking cessation patients.1,5–11
Most common adverse reactions (1 in 10) are mild/moderate nausea, insomnia, headache, abnormal dreams and nasopharyngitis.1
Latest guidance on safe levels of nitrosamines
This tablet option was withdrawn due to concerns over nitrosamine impurities.12
Nitrosamines are carcinogenic chemical compounds, formed when nitrates or nitrites react with amines.13 As well as in cigarette smoke, they can be found in alcoholic drinks, meat and cosmetics.13
To reflect evolving and highly technical evidence, the FDA renewed their recommended acceptable intake limits for nitrosamine in August 2023, stating an acceptable level of 400 ng/day for N-nitroso-varenicline.14
Laboratory tests show that 2 mg varenicline per day (highest daily dose) contains less than 400 ng of nitrosamine.15**
The drive for a smoke-free country
Smoking continues to be the leading cause of preventable heart disease, stroke and respiratory illness.16
2 out of 3 people who continue to smoke will die due to their tobacco use.17, 18
Smoking cessation in at risk patient groups is a priority health strategy
In 2019, the government set out for England to be smoke-free by 2030, with a target of only 5% of the population still smoking.19
Researchers estimate that varenicline not returning would lead to 4,200 fewer people giving up smoking long-term each year.12
Leading to an estimated smoking related 1,890 deaths each year.12
Potential of varenicline in your different smoking cessation patients
Varenicline is indicated for smoking cessation in adults1
47%
Choose varenicline in your stable cardiovascular disease patients
47% remained abstinent during weeks 9-12 vs 14% with placebo8
42%
Choose varenicline in your patients with mild-to-moderate COPD
42% remained abstinent during weeks 9-12 vs 9% with placebo7
45%
Varenicline can pack a punch in relapsed smokers:††
45% remained abstinent during weeks 9-12
20% remained abstinent at 1 year
vs 12% and 3% respectively with placebo6
32%
Varenicline can go the distance with smokers quitting gradually:¶
32% maintained abstinence during weeks 15-24
27% continued abstinence from week 21 to 1 year
vs 7% and 10% respectively with placebo11
Product Information and Resources
|
Varenicline |
|
|---|---|
| Legal Classification | POM |
| Strength |
0.5mg Film-Coated Tablets 1mg Film-Coated Tablets |
| Pack Sizes |
28 (0.5mg & 1mg) 56 (0.5mg) |
Varenicline is available now
Footnotes:
COPD, Chronic Obstructive Pulmonary Disease
*NRT, nicotine replacement therapy
**Below the limit of quantification
††494 people smoking ≥10 cigarettes/day with at least one prior quit attempt using varenicline, but no attempt in the last 3 months
¶24 weeks of varenicline vs placebo in 1510 cigarette smokers not willing or able to quit within the next month, but willing to reduce smoking and attempt quitting within 3 months
References
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Varenicline, Summary of Product Characteristics. TEVA UK Limited.
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Coe JW, et al. J Med Chern 2005;48:3474–77.
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Mills EJ, et al. Ann Med 2012;44:588–597.
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Aubin H-J, et al. Thorax 2008:63:714–724.
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Jorenby DE, et al. Jama 2006;296(1):56-63.
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Gonzales D, et al. Clin Pharmacol Ther 2014;96(3):390–6.
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Tashkin DP, et al. Tobacco Cessation and Prevention 2011;139(3):591-599.
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Rigotti NA, et al. Circulation 2010; 121(2): 221–229.
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Anthenelli RM, et al. Ann Intern Med 2013;159:390–400.
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Gonzales D, et al. Jama 2006. 296(1):47-55.
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Ebbert JO, et al. Jama 2015; 313(7): 687–694.
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Jackson SE, et al. Addiction 2024; 119(7):1203-1210.
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Robles, H. Enc Tox, 2014;3;58–5.
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US Food and Drug Administration. Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) August 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/updated-information-recommended-acceptable-intake-limits-nitrosamine-drug-substance-related. Accessed August 2024.
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ARC Pharma 24F06584 Certificate Of Analysis. Varenicline film-coated tablets 1mg. August 2024.
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Papadakis S, et al. Local Stop Smoking Services and support: Commissioning, delivery, and monitoring guidance. National Centre for Smoking Cessation and Training; 2024.
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NHS England. Tobacco Dependency Programme. https://www.england.nhs.uk/ourwork/prevention/tobacco-dependency-programme. Accessed July 2024.
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UK Health Security Agency. Smoking attributable deaths in England: When the information changes. https://ukhsa.blog.gov.uk/2021/07/06/smoking-attributable-deaths-in-england-when-the-information-changes/. Accessed July 2024.
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Making smoking obsolete, 2022. https://www.gov.uk/government/publications/the-khan-review-making-smoking-obsolete/making-smoking-obsolete-summary. Accessed July 2024.
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